(a) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:
(1) The patient's or human research subject's identity is verified before each administration; and
(2) Each administration is in accordance with the written directive.
(b) At a minimum, the procedures required by paragraph (a) of this section must address the following items that are applicable to the licensee's use of byproduct material--
(1) Verifying the identity of the patient or human research subject;
(2) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;
(3) Checking both manual and computer-generated dose calculations; and
(4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by Sec. Sec. 35.600 or 35.1000.
(c) A licensee shall retain a copy of the procedures required under paragraph (a) in accordance with Sec. 35.2041. [67 FR 20370, Apr. 24, 2002, as amended at 72 FR 45151, Aug. 13, 2007]